After reading the Executive Summary of IOM Article – ‘To Err Is Human’, in about than three pages: .? share your thoughts on why

On December 1, 1999, the Institute of Medicine (IOM) released To Err is Human: Building a Safer Health System,* which revealed that an estimated 44,000 to 98,000 people die annually from med- ical errors (Committee on the Quality of Health Care in America, 1999). Accord- ing to the Report, “more people die in a given year as a result of medical errors than motor vehicle accidents (43,458), breast cancer (42,297), or AIDS (16,516)” (p. 22). The Report also estimates that total national costs encompassing lost income, lost household production, dis- ability, and health care costs of prevent- able adverse events are estimated to be between $17 and $29 billion annually, 50% of which are direct health care costs. The Report has drawn strong responses from Congress, the White House, and health professional organizations. The medical errors issue is anticipated to re- ceive a lot of attention by the federal government and Congress in the year 2000.

WHAT IS THE IOM? The Institute of Medicine was chartered in 1970 by the National Academy of Sci- ences to involve accomplished mem- bers of health professions in the exami- nation of public health policy. The IOM operates the Academy’s congressional charter to advise the federal government and to identify medical care, research, and education issues. In June 1998, the IOM formed a 19-member interdiscipli- nary panel called the Committee on the Quality of Health Care in America to commence a multi-year study of health

delivery in the United States. The Com- mittee published the report To Err is Hu- man: Building a Safer Health System in December 1999. The report was indepen- dently reviewed by 11 additional per- sons to ensure that it met standards for objectivity, evidence, and responsive- ness to the study objectives (Committee on Quality of Health Care in America, 1999).

A variety of methodologies were used to obtain the highlights of To Err is Hu- man: Building a Safer Health System, in- cluding extrapolating regional data to project national costs for medical errors, calculating medication error rates from existing studies, and conducting a meta- analysis of published studies on health care quality and patient safety.

The Committee found that although errors may be more easily detected in hospitals, they occur in every health care setting: day-surgery and outpa- tient clinics, retail pharmacies, nursing homes, and home care. Deaths from medication errors that take place both in and out of hospitals—more than 7000 annually—exceed those that occur as a result of workplace injuries.

The Committee found that the major- ity of medical errors do not result from

individual recklessness but because of systemic flaws in the way the health sys- tem is organized. Among the flaws is il- legible writing in medical records, which has resulted in administration of a drug for which the patient has a known al- lergy. Medical knowledge and technol- ogy are growing so rapidly that it is diffi- cult for practitioners to keep current on an increasing variety of drugs, medical equipment, and case complexities. More- over, coordination of care by the health care team is lacking. For example, when a patient is treated by several practition- ers, they often do not have complete in- formation about all the medications pre- scribed or the complete health history of a patient.

To achieve a better safety record, the IOM Committee recommended a 4- part plan designed to create both finan- cial and regulatory incentives that may lead to a safer health care system, including the following:

National Center for Patient Safety Congress should create a center for pa- tient safety within the U.S. Department of Health and Human Services (DHHS) that would set national safety goals, track progress in meeting them, and in-

LEGISLATIVE NEWS

“To Err is Human”: A Report from the Institute

of Medicine

DEPARTMENTPHC

SECTION EDITOR

D e b ra H a r d y H a v e n s , B S , R N , F N P Wa s h i n g t o n R e p r e s e n t a t i v e f o r N A P N A P C a p i t o l A s s o c i a t e s , I n c Wa s h i n g t o n , D C

D e b r a H a r d y H av e n s , B S , R N , & L i z b e t B o r o u g h s , BA , M S P H

*A copy of To Err is Human: Building a Safer Health System may be downloaded from the World Wide Web at http://www.nap.edu/books/0309068371/html/ or it may be ordered by calling the National Academy of Sciences at (800) 624-6242.

Lizbet Boroughs is an Associate at Capitol Associates, Inc, Washington, DC.

J Pediatr Health Care. (2000). 14, 77-80.

Copyright © 2000 by the National Association of Pediatric Nurse Associates & Practitioners.

0891-5245/2000/$12.00 + 0 25/8/105383 doi:10.1067/mph.2000.105383

March/April 2000 77

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vest in research to learn more about pre- venting mistakes.

Mandatory and Voluntary Reporting Systems A nationwide, mandatory public re- porting system should be established to learn about medical treatments that lead to serious injury or death and to prevent future occurrences. First hospi- tals, and eventually other places where patients get care, would be responsible for reporting such events to state gov- ernments. Currently, about a third of the states have their own mandatory re- porting requirements.

Although the Committee believes that the public has a right to know about errors resulting in serious harm, it nevertheless recommends federal legislation to protect the confidentiality of certain information. This legislation would encourage the growth of volun- tary, confidential reporting systems so that practitioners and health care orga- nizations can correct problems before serious harm occurs. Without such leg- islation, fears that reported information might ultimately be subpoenaed and used in lawsuits could discourage par- ticipation by health care organizations and providers.

Regulatory and Accreditation Measures Regulators and accreditors should make patient safety a key component of their evaluations. As noted in the Report, the clinical performance of most health care professionals is not assessed once they receive their license to practice. Licens- ing and certifying bodies should imple- ment periodic re-examinations of doc- tors, nurses, and other key providers,

based on both competence and knowl- edge of safety practices.

The IOM Committee believes that the U.S. Food and Drug Administration should increase its attention to public safety. Efforts should be made to elimi- nate similar-sounding drug names, as well as confusing labels and packaging that foster mistakes.

Make Safety a Priority Health care organizations must create and foster an environment in which safety will become a top priority. The Report stresses the need for leadership by executives and clinicians and in- creased accountability for patient safety by boards of trustees. This goal entails the creation and funding of systems to monitor safety. The Committee recom- mends that all hospitals and health care organizations implement proven med- ication safety practices, such as using automated drug-ordering systems.

The Report emphasizes that there are no “magic bullets” and that no single component of the IOM plan will be suf- ficient to bring about the degree of change needed. The responsibility for taking action should not be borne by any single group of providers but must be addressed by all parts of the health care enterprise.

CONGRESSIONAL RESPONSE Senator Specter (R-PA), Chairman of the Education Appropriations Subcommit- tee of the Senate Labor, Health and Hu- man Services Committee, held a hearing on the policy implications of the IOM Re- port on December 13. The Specter hear- ing included testimony from a number of health provider organizations that re- sponded to the IOM report. In addition, Senator Kennedy (D-MA) announced his intention to introduce legislation next year based on the report’s recom- mendations. Senator Kennedy hopes to establish a National Center for Patient Safety at the Agency for Healthcare Re- search and Quality (AHRQ) (formerly the Agency for Health Care Policy and Research). The legislation would require hospitals and other health care organiza- tions to report any serious injuries or deaths.

Senators Jeffords (R-VT), Chairman of the Senate Health, Education, Labor and Pension Committee, and Frist (R-TN), Chairman of the Public Health Subcom- mittee, plan to hold hearings on the IOM

report when Congress reconvenes in ear- ly 2000 (McCaffrey, 1999). Senator Frist has stated that the newly reorganized AHRQ may be positioned to implement many of the IOM recommendations. The IOM Report does not address the re- sponsibilities of the AHRQ; however, this may be because the legislation reau- thorizing and reorganizing the Agency passed late in the first session of the 106th Congress.

PRESIDENT RESPONDS TO IOM REPORT On December 7, in response to the IOM Report, President Clinton announced the following 4 initiatives: • Establishing an interagency health care

committee entitled the “Quality Inter- agency Coordination Task Force” to analyze the IOM study and report their recommendations to Vice Presi- dent Gore within 60 days.

• Instructing the government agencies administering health plans (ie, Office of Personnel Management, Health Care Financing Administration [HCFA], Medicare, Medicaid, Department of Defense and Veteran’s Administra- tion) to take steps to reduce medical errors. The Federal Employee Health Benefit Plan will require that the 300+ participating private health plans that insure government employees “insti- tute quality improvement and safety initiatives” next spring.

• Providing the newly reauthorized AHRQ with an additional $25 mil- lion to “improve health care quality and prevent medical errors in an

The medical errors issue is anticipated to receive a

lot of attention by the

federal government and

Congress in the year 2000.

Deaths from medication errors that take

place both in and out of

hospitals—more than 7000

annually—exceed those

that occur as a result of

workplace injuries.

PHC LEGISLATIVE NEWS

JOURNAL OF PEDIATRIC HEALTH CARE March/April 2000 79

Havens and Boroughs

effort to maintain ongoing medical error research.”

• Directing budget and health care offi- cials to include quality and safety ini- tiatives in next year’s federal budget (White House at Work, 1999).

OTHER FEDERAL AGENCY RESPONSES The DHHS Office of Inspector General (OIG) is “calling for HCFA to require all hospitals to report all serious, unexpect- ed adverse drug reactions as a condition for them to participate in Medicare and Medicaid” (OIG: Hospitals Should Re- port, 1999, p. 4). The OIG response is the culmination of a 2-year discussion begun by Senator Edward Kennedy (D-MA) on medication safety. By using HCFA to pressure hospitals to produce adverse drug event reports, the OIG intends to counter the long history of under-report- ing of adverse events and put the pres- sure on hospitals to comply and deliver the reports. In the meantime, public pol- icy officials are anxious to see an upcom- ing report by the General Accounting Of- fice on drug safety, which may spur further action by the Congress and fed- eral government.

HEALTH PROFESSIONAL ORGANIZATIONS RESPOND On December 13, the American Hospi- tal Association (AHA) testified before Senator Specter’s Committee that it be- lieved its efforts should be focused on reducing medication errors, which com- prise the majority of medical mistakes (Health System Errors, 1999). The AHA supports 4 objectives to reduce medica- tion errors: (a) developing a nonpuni- tive process for reporting medication er- rors (the AHA is concerned that an environment of litigation will have a chilling effect on reporting and quickly correcting errors); (b) promulgating best practices medication safety through its advisory “Quality Advisory on Improv- ing Medication Safety”; (c) developing a “medication safety awareness test” for use by hospitals in cooperation with the Institute for Safe Medication Practices; and (d) serving as a clearinghouse for in- formation and resources for hospitals (Health System Errors, 1999).

The AMA issued a statement reinforc- ing its support for assertive systemic measures to be taken to reduce medical errors, that is, “identify, study and solve system-wide problems that can cause

errors” (Health System Errors, 1999). However, the organization remains op- posed to mandatory federal reporting of medical errors. Nancy Dickey, former President of the AMA, said during the Senate hearing on December 13, “We don’t believe at this point that we need a federal mandate.” She further added, “A federal mandate would not improve patient care because it would negate ef- forts to create an environment that fos- ters trust and open communication” (National Journal Group, Inc, 1999).

On the nursing front, the American Nurses Association (ANA) filed a state- ment for the Senate hearing asserting that many medical errors may be avert- ed by focusing on adequate and appro- priate staffing levels throughout hospi- tal settings (Patient Safety and Medical Errors, 1999). The ANA’s statement went further to place blame on hospital sys- tems and administrators for using over- sight and discipline to address individ- ual instances of medical errors rather than “identifying and resolving the cen- tral problem in the spirit of partnership” (Patient Safety and Medical Errors, 1999).

John Eisenberg, MD, Director of the AHRQ, told the Senate Committee of the Agency’s commitment to reducing med- ical errors in fiscal year 2000 (Statement on Medical Errors, 1999). The AHRQ funded the landmark study cited in the IOM Report that found that 78% of all ad- verse drug events are the result of system

failures, not individual mistakes. AHRQ has recently been reorganized and reau- thorized by Congress to focus federal ef- forts on monitoring health care quality. AHRQ has expanded its research com- mitment to monitor and ameliorate med- ical safety errors by doing the following: • Funding research on how informa-

tion systems can be used to identify and prevent medical mistakes and compromises of patient safety;

• Supporting efforts to translate research into practice; and

• Identifying target tools and approach- es from other industries that could be applied in the health care arena. Dr Eisenberg suggested that the health

care industry consider adopting similar safeguards that exist in the airline in- dustry by facilitating “teamwork, guide- lines, automation, simplification and standardization” (Statement on Med- ical Errors, 1999). He cited a study docu- menting a 22% reduction in medication errors involving heparin and insulin af- ter pocket-sized laminated protocols were distributed to the diabetes treat- ment team (Leape et al., 1998).

WHAT PNPs CAN DO • Write chart notes, orders, and pre-

scriptions legibly. One suggestion to ameliorate the problem of illegible writing as cited by the IOM Report was the use of hand-held computers or computerized charting stations to record medications and dosage in- structions by hospitals and large out- patient clinics.

• Ensure that patients know what med- ication they are taking, what the pills look like, and what the medication is treating to increase their compliance.

• Encourage a systems-based approach to solving errors, reiterate medication safety at staff meetings, establish non- punitive environments and systems for reporting errors and accidents, re- duce reliance on memory, encourage standardization of protocols, and uti- lize checklists (Committee on Quality of Health Care in America, 1999).

• Encourage distinctive storage of med- ications that must be diluted before being administered to reduce the like- lihood of mistakes; for instance, Henry Ford Health System, cited in the IOM Report, stores nondiluted medications in double canisters.

• Be proactive. Bring your administra- tors good ideas you may hear about,

The Committee found that the majority of

medical errors do not

result from individual

recklessness but because of

systemic flaws in the way

the health system is

organized.

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80 Volume 14 Number 2 JOURNAL OF PEDIATRIC HEALTH CARE

such as placing color-coded wrist bands on children when they are ad- mitted. The colored bands are coded to the child’s weight, thus quickly as- sisting with the calculation of medica- tion dosages. To Err is Human: Building a Safer Health

System placed a spotlight on the serious issue of medical errors in the United States. The coming months will generate Congressional and legislative responses to the issue, but hospitals, outpatient clinics, and day surgery centers remain the first line in preventing medical mis- takes. Medical safety is everyone’s re- sponsibility; health providers, adminis- trators, accreditors, patients, and their families. Medical errors will not be sig- nificantly reduced until all levels of the health care system cooperate.

REFERENCES

McCaffrey, G. (Ed). (1999, December 14). Senate Panel ponders need for legislation to require re- porting of medical errors. Daily Report for Execu- tives, 239, p. A-33.

Committee on Quality of Health Care in America, Institute of Medicine; Kohn, L., Corrigan, J., & Donaldson, M. (Eds.). (1999).

To err is human: Building a safer health system. Washington, DC: National Academy Press.

Health System Errors: Hearings before the Senate Com- mittee on Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies (1999 December 13) (testimony of the American Medical Association presented by Nancy W. Dickey, MD, AMA Immediate Past President). Available: http://www.senate.gov/ ~appropriations/labor/testimony/dick1213.htm

Leape, L., Kabcenell, A., Berwick, D. (1998). Reducing adverse drug events. Boston: Institute for Health- care Improvement.

National Journal Group, Inc. (1999, December 14). Medical errors: AMA not in favor of mandatory

reporting. American Health Line [On-line serial]. Available: http://nationaljournal.com/aboutahl.htm

OIG: Hospitals should report drug reactions to remain in Medicare. (1999, December 17). Inside HCFA, 4.

Patient safety and medical errors: Hearings before the Senate Committee on Appropriations Subcom- mittee on Labor, Health and Human Services, Edu- cation and Related Agencies (December 13, 1999) (testimony of Mary Foley, First Vice President, American Nurses Association). Available: http:// www.senate.gov/~appropriations/labor/testimony/ ana1213.htm

Statement on medical errors: Hearings before the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education, (December 13, 1999) (testimony of John M. Eisenberg, MD, Director, Agency for Healthcare Research and Quality). Available: http://www.ahrq.gov/news/ stat1213.htm

White House at Work. (1999, December 7). President Clinton: Taking new steps to ensure patient safety [On-line]. Available: http://www.whitehouse.gov/ WH/Work/120799.html.

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